UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017813 |
|---|---|
| Receipt number | R000020619 |
| Scientific Title | Evaluation test of wrincle improvement effect by application of eggshell membrane cosmetics (Super Odi Grand Evolution) (pilot study) |
| Date of disclosure of the study information | 2015/06/04 |
| Last modified on | 2017/06/20 22:32:27 |
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Basic information
Public title
Evaluation test of wrincle improvement effect by application of eggshell membrane cosmetics (Super Odi Grand Evolution) (pilot study)
Acronym
Evaluation test of wrincle improvement effect by eggshell membrane cosmetics
Scientific Title
Evaluation test of wrincle improvement effect by application of eggshell membrane cosmetics (Super Odi Grand Evolution) (pilot study)
Scientific Title:Acronym
Evaluation test of wrincle improvement effect by eggshell membrane cosmetics
Region
| Japan |
Condition
Condition
wrincle
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study is to reveal the wrincle improvement effect of eggshell membrane cosmetics (super odi grand evolution).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The wrincle depth evaluated by replica of eye area
Key secondary outcomes
The wrincle grade evaluated by a picture of eye area
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply 3 drops of Super Ode Grand Evolution containing hydrolyzed eggshell membrane 3 times a day for 2 weeks to the outer corner of a half face allocated randomly by assignment director.
Interventions/Control_2
Three drops of placebo cosmetic that removed the hydrolyzed eggshell membrane from Super Ode Grand Evolution on the outer corner of the half face randomly assigned by assignment director were applied three times a day for 2 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Age ranges from 30 to 60
(2) female
(3) those who mainly have wrinkles of wrinkle grade 1 to 3
(4) Person who obtains consent of voluntary participation in examination by document
Key exclusion criteria
(1) Person who has a history of allergy
(2) Those receiving hormone replacement therapy
(3) During pregnancy, breast-feeding
(4) Persons who have experienced cosmetic care that will affect the site to be examined
(5) A patch test was conducted on the test cosmetics and the replica agent, and a person with abnormality appeared on the skin
(6) Person who is receiving facial beauty treatment
(7) Others who acknowledge that doctors involved in the examination are not appropriate
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Watanbe |
Organization
Tokyo University of Agriculture and Technology
Division name
Graduate School of Engineering, Department of Applied Chemistry
Zip code
Address
2-24-16 Nakacho, Koganei, Tokyo
TEL
042-388-7289
toshi@cc.tuat.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Shimizu |
Organization
Tokyo University of Agriculture and Technology
Division name
Grad Sch of Eng, Dept of Appl Chem
Zip code
Address
2-24-16 Nakacho, Koganei, Tokyo
TEL
042-388-7539
Homepage URL
mshmz@cc.tuat.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture and Technology
Institute
Department
Personal name
Funding Source
Organization
Almado Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京農工大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 04 | Day |
Last modified on
| 2017 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020619
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
